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临床试验/CTRI/2025/07/091287
CTRI/2025/07/091287尚未招募不适用

Biomechanical and anthropometric alterations in the foot following toe amputation

Dean1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
Determining differences in anthropometric changes and biomechanical modifications between the amputated and contralateral normal foot

研究概览

简要总结

Patients who visit the Surgery OPD with a toe amputation done atleast 6 months prior, will be invited to participate in this study. Prior to inclusion, informed consent will be obtained from each participant. The study will involve a comprehensive evaluation of both the amputated and normal foot using various parameters. This includes collecting data available in the EMR or Medical Records available with the patient from an outside hospital, as mentioned in the proforma. The foot is then assessed by measuring bilateral foot circumferences, foot posture, range of motion, height of medial arch, contact area of the foot and eversion / valgus at the ankle joint. Pre and post operative plain x rays of the foot, if available (done by the treating physician or outside hospital) will also be assessed. Pressure points will be identified and compared to those of the normal foot using a static podogram. Sensory and motor deficits will be documented. The data collected from these assessments will be compared with those of the contralateral normal foot.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients who have undergone unilateral toe amputation, at least 6 months prior to index visit
  • Anatomically normal contralateral foot.

排除标准

  • Previous surgeries of the foot other than the toe amputation as index procedure
  • Pre-existing musculoskeletal deformity
  • Pre-existing neurological deficits except diabetic neuropathy.

结局指标

主要结局

Determining differences in anthropometric changes and biomechanical modifications between the amputated and contralateral normal foot

时间窗: 1 week

次要结局

  • 1. Documentation of pressure distribution and specific points of high pressure on both the amputated and normal foot in a static podogram(2. Documentation of any complications or adverse outcomes associated with foot health, such as ulcers or callosity in either the amputated foot or contralateral normal foot)

研究者

发起方
Dean
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Devesh Joshi

Kasturba Medical College, Manipal

研究点 (1)

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